SOP FOR OPERATION AND CLEANING OF MULTI MILL
OBJECTIVE: To lay down the procedure for operation and cleaning of Multi mill.
SCOPE: This procedure is applicable for operation and cleaning of Multi mill.
RESPONSIBILITY:
It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during use of Multi mill.
Officer/Supervisor or designee of IPQA is responsible for the line clearance and verification of the related documents along with ensuring the compliance of SOP.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the machine if any break down occurs during the operation.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
ACCOUNTABILITY: Head of the Production Department.
PROCEDURE:
Pre-startup (In the beginning of shifting):
Ensure that no remnants of previous product/batch are present.
Visually check the equipment and area for its cleanliness.
Ensure “cleaned” label status on the equipment.
Check the cleanliness of the room.
Check the material kept in the room and ensures that it is of the same batch to proceed.
Check the room temperature and relative humidity and record it in BMR. If it is not within the limit inform the maintenance department and do not proceed till it gets rectified.
Check the integrity of the Screen of the multimill. If it is damaged, change it with intact one.
Operation:
Before start the operation production officer get the line clearance from QA person and affix the status label with product name. Batch detail to equipment and area.
Fix the beater assembly.
Fit he screen of required size and the hopper properly.
Set the Multi mill in required direction by moving the knob. Then adjust the required speed.
Tie the poly bags to the discharge chute of Multi mill by cable tie and keep the poly bags in stainless steel. In process container and then place container below the discharge port.
Put ON the mains, then press green button and load the material, adjust the chute plate so that material will feed slowly and checks for smooth functioning of the machine.
Control the flow with stopper plate and ensure that the hopper is not charged heavily otherwise the Multi Mill can get blocked.
Put OFF the mains after completion of the operation.
Record equipment usage in activity log book.
Cleaning at the time of batch changeover/same product of ascending potency(Type-A):
Remove all the left over powder particles on the machine using vacuum cleaner and lint free mop.
Clean powder tray, chute, multi chamber and machine body by wiping using dry lint free mop.
After cleaning affix the “CLEANED” status label on the equipment.
Record the cleaning details in the activity log book.
Cleaning at the time of product changeover/same product of descending potency/after preventive maintenance of the contact parts(Type-B):
Dismantle following and take those to washing area:
Chute
Multi chamber
Clean all the parts with purified water.
Finally wash with purified water thoroughly.
Rinse the dismantled parts with purified water and intimate to IPQA to collect the rinse water sample.
IPQA will send the rinse water sample to Q.C. department to confirm the absence of previous product
Dry the parts using lint free mop.
Clean the machine with a wet lint free mop followed by dry lint free mop.
Clean the room thoroughly.
Sanitize the all parts with 70% IPA solution and assemble.
Affix “CLEANED” status label.
Record the cleaning details in activity log book.